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Surufatinib

Extended indication Patients with low- or intermediate grade (G1 or G2) advanced extrapancreatic neuroendocrine tumors.
Therapeutic value No estimate possible yet
Registration phase Registration application pending

Product

Active substance Surufatinib
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Neuroendocrine cancer
Extended indication Patients with low- or intermediate grade (G1 or G2) advanced extrapancreatic neuroendocrine tumors.
Manufacturer Hutchison MediPharma
Mechanism of action Angiogenesis inhibitor
Route of administration Oral
Budgetting framework Intermural (MSZ)
Additional remarks Surufatinib inhibits tyrosine kinase activity associated with VEGFR and FGFR. Grade 1 (low-grade tumor): These cells divide at a low rate and therefore grow slowly. Grade 2 (intermediate-grade tumor): These cells divide at an intermediate rate.

Registration

Registration route Centralised (EMA)
Submission date July 2021
Expected Registration August 2022
Orphan drug Yes
Registration phase Registration application pending
Additional remarks Fabrikant heeft aangegeven registratie bij de FDA te plannen, wanneer indiening bij de EMA plaats zal vinden is nog niet bekend.

Therapeutic value

Current treatment options Huidige behandelopties zijn beperkt, met name chirurgie.
Therapeutic value No estimate possible yet
Frequency of administration 1 times every 4 weeks
Dosage per administration 300 mg
References NCT02588170

Expected patient volume per year

References NKR
Additional remarks Jaarlijks krijgen in Nederland ruim 700 mensen een neuro-endocrine tumor. 9% van alle neuro-endocrine tumoren ontstaan in de pancreas. Het patiëntaantal voor deze indicatie zal beperkt zijn. Bij komende indicatie-uitbreidingen zullen grotere patiëntvolumes gemoeid zijn.

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Overige Neuro Endocriene Tumoren en Biliary cancer.
References Clinicaltrials.gov; Adisinsight.
Additional remarks Lopende fase 3 studies.

Other information

There is currently no futher information available.